To evaluate the influence of BR9006-1 and BR9006-2 on pharmacokinetics, safety, and tolerability when administered separately or co-administered to healthy male volunteers.
A total of 36 subjects will be enrolled in one sequence group. The investigational products will be administered according to the treatment groups (T, M, T+M) assigned to one sequence group in Period 1, Period 2, and Period 3.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
* Administration to the T/T+M group: 0.2 mg of BR9006-1 will be administered one capsule once a day, five-day repeated-dose
* Administration to the M group: 50 mg of BR9006-2 will be administered one tablet once a day, eleven-day repeated-dose * Administration to the T+M group: 50 mg of BR9006-2 will be administered one tablet once a day, five-day repeated-dose
CHA Bundang Medical Center, CHA University
Seongnam-si, Gyeonggi-do, South Korea
Pharmacokinetic variables - Maximum (peak) steady-state plasma drug concentration during a dosage interval(Cmax,ss) of Part A and B
The analysis to investigate drug-drug interaction shall be divided into two parts: Part A (Tamsulosin vs. Tamsulosin + Mirabegron) and Part B (Mirabegron vs. Mirabegron + Tamsulosin).
Time frame: 0~26 days after medication
Pharmacokinetic variables - Area under the plasma concentration-time curve from time zero to time t(AUCt) of Part A and B
The analysis to investigate drug-drug interaction shall be divided into two parts: Part A (Tamsulosin vs. Tamsulosin + Mirabegron) and Part B (Mirabegron vs. Mirabegron + Tamsulosin).
Time frame: 0~26 days after medication
Pharmacokinetic variables - Time to reach maximum (peak) plasma concentration following drug administration at steady state (Tmax,ss) of Part A and B
The analysis to investigate drug-drug interaction shall be divided into two parts: Part A (Tamsulosin vs. Tamsulosin + Mirabegron) and Part B (Mirabegron vs. Mirabegron + Tamsulosin).
Time frame: 0~26 days after medication
Pharmacokinetic variables - Minimum steady-state plasma drug concentration during a dosage interval (Cmin,ss) of Part A and B
The analysis to investigate drug-drug interaction shall be divided into two parts: Part A (Tamsulosin vs. Tamsulosin + Mirabegron) and Part B (Mirabegron vs. Mirabegron + Tamsulosin).
Time frame: 0~26 days after medication
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